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NCT01571362 · ClinicalTrials.gov registry record · Phase 3
A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 410
- Enrollment target
NCT01571362: Completed Phase 3 study, sponsored by Pfizer.
NCT01571362 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 410 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01571362, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 410 participants
- Enrollment target
Study Summary
The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
Primary Outcome
Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.
Interventions
- DRUG Placebo
- DRUG ALO-02
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT01571362 record still lists
NCT01571362 is an interventional study that assigns participants to a tested intervention. The registered 410 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01571362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01571362 about?
NCT01571362 is a clinical study titled "A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain". The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
What is the current status of trial NCT01571362?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 410 participants. The study started on 2012-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01571362?
The interventions under investigation include: Placebo (DRUG), ALO-02 (DRUG).
Who is sponsoring clinical trial NCT01571362?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01571362's enrollment target sits among peer trials
410 909th of 2000 higher than 1,090 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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